Contract Research and Development Organizations-Their History, Selection, and Utilization [Hardcover]

This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics:

?        The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went.

?        Study directors and principal investigators.

?        The nuts and bolts of study performance.

?        Electronic reporting requirements  SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions).

?        Consultants and their roles.

?        An expanded examination of common problems and their solutions.

This book boastscomplete directories to the global universe of operating labs  where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities  and for auditing studies and projects at such facilities  are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves.